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. Author manuscript; available in PMC: 2017 Jul 1.
Published in final edited form as: Cancer Epidemiol Biomarkers Prev. 2016 May 17;25(7):1037–1042. doi: 10.1158/1055-9965.EPI-15-1221

Figure 1. Overview of sensitivity and specificity determination based on our two studies, either Study A: populations of women with diagnosed breast cancer or Study B: populations of women with positive Clinical Breast Exam (CBE)/mammography but before diagnosis.

Figure 1

(A) Patients with invasive breast malignancy were used to determine sensitivity of an assay based on CAML presence. Healthy controls were used to determine the specificity. (B) The assay was then tested using patients with positive breast mammography, or positive CBEs, for CAML presence by standard blood draw at the time core biopsy was taken. Standard pathological assessment was used to determine invasive malignant disease, benign condition, or non-invasive disease/Stage 0. Patient information was then unblinded and sensitivity/specificity of CAMLs in relation to pathological assessment was compared.